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Immunomodulator
Povetacicept for Autoimmune Kidney Diseases (RUBY-3 Trial)
Phase 1 & 2
Recruiting
Research Sponsored by Alpine Immune Sciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up study day 1 through 90 days after last dose of study drug
Awards & highlights
No Placebo-Only Group
Summary
This trial will assess if a drug (povetacicept) is safe & potentially beneficial in treating IgA nephropathy, membranous nephropathy & lupus nephritis. Participants receive drug every 4 weeks for 6 months, with the possibility of a 6-month extension.
Who is the study for?
Adults with certain autoimmune kidney diseases like IgA nephropathy, membranous nephropathy, or lupus-related kidney disease can join. They must have a confirmed diagnosis through biopsy and meet specific criteria including protein levels in urine and antibody presence. Stable immunosuppression treatment is required for some conditions before starting the trial.
What is being tested?
The study tests povetacicept (ALPN-303) to see if it's safe and effective for treating autoimmune kidney diseases. Participants will receive doses every four weeks for six months, with an option to continue for another six months.
What are the potential side effects?
Possible side effects of povetacicept are not detailed here but may include reactions related to immune system changes since it targets autoimmune processes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ study day 1 through 90 days after last dose of study drug
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~study day 1 through 90 days after last dose of study drug
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Adverse Events
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: povetacicept 80mgExperimental Treatment1 Intervention
Group II: povetacicept 240mgExperimental Treatment1 Intervention
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Who is running the clinical trial?
Alpine Immune Sciences, Inc.Lead Sponsor
8 Previous Clinical Trials
530 Total Patients Enrolled
Jiahua Li, M.D.Study DirectorAlpine Immune Sciences, Inc.
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with another kidney disease.My kidney function is severely reduced.I was diagnosed with IgA nephropathy less than 10 years ago and have a UPCR of 0.5 or higher without any immunosuppression treatments.I have not had a serious infection recently or ongoing.I have a kidney condition confirmed by a biopsy and specific antibodies, with high protein levels in my urine or not enough decrease in protein despite treatment.I have active lupus affecting my kidneys, confirmed by a biopsy and tests, and have been on stable immunosuppression.I have not received B cell or anti-BAFF/APRIL therapies recently.I have a kidney condition confirmed by biopsy to be IgAN, pMN, or LN.
Research Study Groups:
This trial has the following groups:- Group 1: povetacicept 80mg
- Group 2: povetacicept 240mg
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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